Results from the long-term extension (LTE) of the Phase 3 TRAILBLAZER-ALZ 2 study were released by Eli Lilly and Company (NYSE: LLY). A comparison with an untreated external cohort from the Alzheimer’s Disease Neuroimaging Initiative (ADNI) revealed that participants treated with Kisunla (donanemab-azbt) showed a slowing of decline, a benefit that increased over the course of three years.
Even study participants who began treatment later experienced positive outcomes. However, compared to research participants who received Kisunla treatment later, those who started Kisunla earlier had a considerably lower probability of the disease progressing to the next stage. These findings were presented at the 2025 Alzheimer’s Association International Conference (AAIC) in Toronto as a late-breaking presentation.
The TRAILBLAZER-ALZ 2 long-term extension reaffirms that Kisunla delivered sustained clinical benefit that continued to increase over three years and a consistent safety profile,
Participants continued to show meaningful outcomes, reinforcing the long-term value of early intervention.
Mark Mintun
A Phase 3 double-blind extension of the initial TRAILBLAZER-ALZ 2 trial, the TRAILBLAZER-ALZ 2 LTE research assessed Kisunla’s safety and effectiveness in people with early-stage Alzheimer’s disease symptoms. Those initially on a placebo started Kisunla blindly, whereas those initially on Kisunla either continued therapy or were moved to a placebo. Results were compared to a matched, untreated population using an external comparator group from ADNI.
Read More: Eli Lilly Responds to EMA’s Donanemab Marketing Authorization Rejection
TRAILBLAZER-ALZ 2 LTE Study Results
- Increasing Long-Term Benefit: Over a three-year period, Kisunla’s efficacy in delaying cognitive decline rose in comparison to a matched group that was not involved in the trial.
- Benefit of Early Treatment: Compared to individuals who began treatment later, those who began Kisunla medication earlier had a 27% decreased chance of the disease progressing to the next stage.
- High Amyloid Clearance: Within 76 weeks of beginning Kisunla medication, over three-quarters of subjects had amyloid plaque cleared.
- Slow Plaque Reaccumulation: After completing their term of treatment, individuals’ amyloid plaque recovered relatively slowly, indicating that the medication had a long-lasting effect.
- Verified Safety Profile: Throughout the three-year study, no new safety concerns were found, confirming Kisunla’s proven safety and tolerability.
Within the class of amyloid-targeted medicines, hemorrhage/with hemosiderin deposition and amyloid-related imaging abnormalities (ARIA) with edema/effusion (ARIA-E) are side effects that typically do not elicit any symptoms, but they can induce severe and potentially fatal symptoms. ARIA can be lethal. Alzheimer’s disease and ARIA may be more likely to occur in people who carry one or two copies of the apolipoprotein E ε4 (ApoE4) gene. Patients should talk to their healthcare providers about any safety concerns. Additionally, Kisunla may result in some allergic responses, usually during infusion or within 30 minutes after infusion, some of which may be severe and potentially fatal. 2, 3 Another often reported adverse effect is headache.
About TRAILBLAZER-ALZ 2 Long-Term Extension Study
After reaching predetermined amyloid clearance criteria, participants (n=550) who had previously received Kisunla medication in the main study were either switched to a placebo or continued treatment in the LTE. In order to evaluate the long-term Kisunla safety and durability of therapy effects, these subjects were monitored during the LTE period.
In order to assess delayed treatment outcomes, participants in the main study who had received a placebo switched to Kisunla at the beginning of the LTE period in a blinded fashion. Kisunla was given to these delayed start patients (n = 657) using the same dosage, mode of administration, and discontinuation guidelines as the TRAILBLAZER-ALZ 2 experiment. Patients were eligible for the trial if their amyloid plaque level was less than 11 centiliters on a single PET scan or between 11 and 25 centiliters on two consecutive PET scans.
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Graduated from the University of Kerala'20 with B.Sc. Botany & Biotechnology. Post-graduation in Biotechnology from the University of Kerala'22. Internship experience in Cancer Research.
